Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Wednesday, October 17, 2018
FDA Warns Two Firms about Monensin Contamination in Horse Feed
The U.S. Food and Drug Administration has issued warning letters to two feed mills, Gilman Co-Op Creamery in Gilman, Minnesota, and Farmers/Ranchers Cooperative Association of Ainsworth in Ainsworth, Nebraska, that mixed horse feed containing monensin. Monensin is an animal drug approved for use in cattle, swine, and poultry that is highly toxic and potentially lethal to horses, even at relatively low levels.
These firms did not adhere to the Current Good Manufacturing Practice (CGMP) requirements for medicated feed mills. They are also subject to FDA’s Preventive Controls for Animal Food regulations. The medicated feed CGMPs require firms to conduct appropriate sequencing or adequate equipment cleanout procedures when switching from mixing a medicated animal food to a non-medicated one. These regulations are designed to prevent unsafe cross-contamination between medicated feed and non-medicated feed or other medicated feed.